Label: FISSURE CONTROL- calendula officinalis flowering top and hamamelis virginiana root bark/stem bark solution/ drops
- NDC Code(s): 51393-6334-1, 51393-6334-2, 51393-6334-5
- Packager: Forces of Nature
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated April 24, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Also Contains
- Indications
- Directions
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Warnings
Do not put this product into the rectum by using fingers or any mechanical device or applicator. Some individuals may be sensitive to essential oils. Begin with a small drop to determine if the product causes any increased redness or irritation and discontinue use if it irritates your skin. For external use only. If accidental ingestion of more than several drops, and adverse reaction occurs, get medical help or contact a Poison Control Center. Do not apply to the eyes. If you are pregnant or breast-feeding, ask a health professional before use. Not for use on children under the age of 2 without physician direction.
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Tips For Use
Fissure Control's soothing ingredients offer immediate relief from pain and discomfort caused by fissures. It also quickly repairs the damaged tissue and encourages your body to heal itself faster than it would be able to without the medicine.
The pain relief can often be felt immediately. Torn skin is typically healed within one week, but more severe cases may require longer treatment time. The healing time can be made longer or shorter, depending on a few factors including:
- Constipation and straining during bowel movements.
- The length of time your fissure has existed - The longer the symptom has been present the longer the treatment will take.
- Your application schedule - Fissure Control should be applied at least 2-3 times every day while the symptom exists.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 5 ml Bottle Label
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INGREDIENTS AND APPEARANCE
FISSURE CONTROL
calendula officinalis flowering top and hamamelis virginiana root bark/stem bark solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51393-6334 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 6 [hp_X] in 1000 mL HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 6 [hp_X] in 1000 mL Inactive Ingredients Ingredient Name Strength CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9) Lavandin Oil (UNII: 9RES347CKG) Sesame Oil (UNII: QX10HYY4QV) HELICHRYSUM ITALICUM FLOWER OIL (UNII: O97ZV7726K) Product Characteristics Color BLUE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51393-6334-1 11 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 04/06/2011 2 NDC:51393-6334-2 33 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 04/06/2011 3 NDC:51393-6334-5 5 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED HOMEOPATHIC 04/06/2011 Labeler - Forces of Nature (050169130)
